Fluid Biopsy for the Diagnosis of Lung Cancer

Lung Carcinoma Clinical Trial

Official title:

Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162678
• Other study ID #: 2N-19-3
• Secondary ID: NCI-2019-058612N
• Status: Recruiting
• Start date: January 13, 2020
• Est. completion date: January 13, 2026

Study information

• Verified date: June 2023
• Source: University of Southern California
• Contact: Sandy Tran, RN
• Phone: 323-865-0451
• Email: Sandy.Tran[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.

Description:

PRIMARY OBJECTIVE: I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma. SECONDARY OBJECTIVES: I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer. II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype. OUTLINE: Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening. After completion of study, patients are followed for up to 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 13, 2026
• Est. primary completion date: January 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo a diagnostic biopsy for possible lung cancer or
• Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
• Planning or completed in the last 2 weeks a CT lung cancer screen
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
• Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood via HD-SCA fluid biopsy

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Liquid Biopsy
Undergo collection of blood via HD-SCA fluid biopsy

Other:
• Medical Chart Review
Review of medical chart

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical diagnosis of lung cancer	Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.	Within 90 days of tissue biopsy